Weizman 2021.

Study characteristics
Methods	Study design: cluster‐RCT Study duration: January 2017 to January 2018 Setting: tertiary IBD centres
Participants	State of disease at beginning of study per IG/CG: all participants had active disease flare‐ups Disease type per IG/CG: 91 patients with UC Inclusion criteria: people with a known diagnosis of UC admitted to hospital for an acute disease flare between January 2017 and January 2018. Only the first UC flare hospitalisation during the study period was included for each participant. Exclusion: people with CD and those unable to provide informed consent Age at beginning of study per IG/CG: the figures reporting age were labelled 'age at admission' and did not state the nature of the numbers provided; they are probably mean (spread) values, but presented in the source material as "n(%)": IG: 32.1 (11.4%); CG: 35.6 (12.6%) Sex per IG/CG: IG: 21/46 males and 25/46 females CG: 22/45 males and 23/45 females Disease duration per IC/CG: NR Number randomised per IG/CG: CG: 45; IG: 46 Number reaching end of study per IG/CG: CG: 42; IG: 45
Interventions	IG (educational intervention): participants were provided with an iPad containing specific patient‐directed educational material which focused on the optimal in‐hospital management of acute severe UC. The educational intervention was an original, interactive video that provided a summary of the 2012 Canadian consensus statements on the treatment of hospitalised adult patients with severe UC, and it used a patient‐friendly languages and images. CG: standard care
Outcomes	Duration of follow‐up: 6 months Total duration of the study was 12 months Primary outcomes as defined by study authors: patient‐reported outcomes: Trust in Physician Scale (SD), Global CACHE score using questionnaire, hospital anxiety and depression score (HADS), and clinical outcomes, which were overall length of stay, the development of hospital‐acquired venous thromboembolism and the occurrence of colectomy. Secondary outcomes as defined by study authors: NR
Notes	Funding source: funded in part through an unrestricted educational grant from Abbvie Conflicts of interest: A.V.W. has served as an advisory board member for Abbvie, Janssen, Takeda, Ferring and as a speaker for Abbvie, Janssen, Takeda, Ferring, Pfizer; B.B. has served as an advisory board member and speaker for Ferring, Janssen, Abbvie, Takeda, Pfizer, Novartis, Merck, an advisory board member for Robarts Clinical Trials, Celgene, Microbiome Insights, Merck, Amgen, Pendopharm, Genentech, BMS, Allergan, Protagonist and has received research support from Janssen, Abbvie, GSK, BMS, Amgen, Genentech, Merck, BI, Qu Biologic, Celgene, Alvine. He owns stock options in Qu Biologic; C.H.S. has served as an advisory board member for Janssen, Abbvie, Takeda, Ferring, Shire, Pfizer and as a speaker for Janssen, Abbvie, Takeda, Ferring, Shire, Pfizer; W.A. has served as an advisory board member for Janssen, Abbvie, Takeda, Merck, Pfizer and has received research support from Theradiag, Prometheus; N.M.A.: none; L.T. has served as an advisory board member for Janssen, Abbvie, Merck, Pfizer, Takeda, Mallinckrodt, as a speaker for Janssen, Takeda and has received research funding from Janssen; D.H.N.: none; J.L.J. has served as an advisory board member for Janssen, Merck, Pfizer, Abbvie, Shire, Takeda and as a speaker for Janssen, Pfizer, Abbvie, Shire, Takeda; V.H.: none; S.K.M. has served as an advisory board member for Takeda, Ferring, Shire, Abbvie and as a speaker for Ferring, Pfizer; G.C.N: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Computer‐generated randomisation was performed centrally. Patients admitted with a UC flare within a specific 6‐month time period were allocated to the intervention designated for that time cluster. At the end of the 6‐month time period, sites that had been randomised to the intervention group would then return to usual care or vice versa (Information provided by the author). Although the clusters were randomised at the same time, the researchers had to decide whether individual patients should be entered into the study which raises the possibility of bias: "All hospital admissions were scanned daily on weekdays by research staff to identify potential enrollees, and suitable participants were approached to participate in the study"
Allocation concealment (selection bias)	Low risk	As this is a cluster‐RCT lack of concealment of an allocation sequence should not be an issue
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible to blind study participants and personnel for this study
Blinding of outcome assessment (detection bias) All outcomes	High risk	The outcome assessors were not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Small number of patients withdrawing with reasons given and no imbalance between IG and CG
Selective reporting (reporting bias)	Low risk	Study has a trial registration NCT02569333) which and the stated outcomes are presented in the results
Other bias	Low risk	No baseline imbalances and clustering taken into account for the analysis. No other concerns.

CCFA: Crohn's & Colitis Foundation of America; CD: Crohn's disease; CDAI: Crohn's Disease Activity Index; CG: control group; GI: gastrointestinal; HBI: Harvey‐Bradshaw Index; HRQoL: health‐related quality of life; IBD: inflammatory bowel disease; IBDQ: Inflammatory Bowel Disease Questionnaire; IG: intervention group; ITT: intention to‐treat; IQR: interquartile range; IV: intravenous; NR: not reported; QOL: quality of life; QuICC: Quality Index in Crohn’s and Colitis; RCT: randomised controlled trial; RFIPC: Rating Form of IBD Patient Concerns; SC: subcutaneous; SD: standard deviation; SCCAI: Simple Clinical Colitis Activity Index; TNF: tumour necrosis factor; UC: ulcerative colitis; UCEIS: Ulcerative Colitis Endoscopic Index of Severity